To Evaluate Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes)

• ClinicalTrials.gov Identifier: NCT05859165
• Recruitment Status: Recruiting
• First Posted: May 15, 2023
• Last Update Posted: May 15, 2023
• Sponsor: Société des Produits Nestlé (SPN)
• Collaborator: Nestle Health Science
• Information provided by (Responsible Party): Société des Produits Nestlé (SPN)

Study Description

Brief Summary:

This study has a parallel, non-inferiority design, comparing the 24h AUC of Nutren Diabetes group with Fresubin Diabetes group at 2-4 days since the start of formal intervention.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus	Dietary Supplement: Nutren Diabetes; Dietary Supplement: Fresubin Diabetes	Not Applicable

Detailed Description:

This is a randomized, active-control, open labelled study in which either Nutren Diabetes or Fresubin Diabetes will be given to patients with diabetes for aound 9 days.

24h AUC, TIR, TBR, prealbumin albumin etc. will be evaluated. And also safety-related laboratory parameters, numbers, severity, outcome of AEs will be evaluated too.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes) for Nutritional Support in Diabetic Patients With Dysphagia
• Actual Study Start Date: February 1, 2023
• Estimated Primary Completion Date: January 10, 2024
• Estimated Study Completion Date: January 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nutren Diabetes group; Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day	Dietary Supplement: Nutren Diabetes; Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
Active Comparator: Fresubin Diabetes group; Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day	Dietary Supplement: Fresubin Diabetes; Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day

Outcome Measures

Primary Outcome Measures :

1. 24h AUC of Nutren Diabetes group with Fresubin Diabetes group [ Time Frame: 2-4 days since the start of formal intervention ]
   mean area under the blood glucose concentration-time curve from time 0 to 24h (24h AUC)

Secondary Outcome Measures :

1. Coefficient of variation of blood glucose [ Time Frame: Day 2 upon formal intervention ]
   CV data from CGM
2. Time in range [ Time Frame: Day 2 - 4 upon formal intervention ]
   TIR from CGM
3. Time above range [ Time Frame: Day 2 - 4 upon formal intervention ]
   TAR from CGM
4. Time below range [ Time Frame: Day 2 - 4 upon formal intervention ]
   TBR from CGM
5. Mean amplitude of glycemic excursion [ Time Frame: Day 2 - 4 upon formal intervention ]
   MAGE from CGM
6. Peak blood glucose [ Time Frame: Day 4 upon formal intervention ]
   Peak blood from CGM
7. Fasting plasma glucose [ Time Frame: Day 7 upon formal intervention ]
   FPG from laboratory test
8. Prealbumin [ Time Frame: Day 7 upon formal intervention ]
   Prealbumin from laboratory test
9. Albumin [ Time Frame: Day 7 upon formal intervention ]
   Albumin from laboratory test

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 1. Male or female aged 18-75 years old (inclusive); 2. Diagnosis of diabetes, and stable use of hypoglycemic drugs for about 1 month (refer to Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020) for the diagnosis of diabetes); 3. Glycosylated hemoglobin (HbA1c) <8.5%; 4. Inability to feed orally; 5. It is estimated that tube feeding would be required for more than 9 days; 6. Patients or their guardians (or authorized personnel) have fully understood the study procedures of this trial and are willing to sign the informed consent form (ICF).

Exclusion Criteria:

• 1. Subjects with congenital metabolism disorder or allergy to any ingredient in the product (such as whey protein, milk protein concentrate, soybean lecithin); those with congenital intolerance to fructose; 2. Patients who are not suitable for enteral nutrition, such as those with active gastrointestinal (GI) hemorrhage, intestinal ischemia, paralytic/mechanical ileus, decreased GI tension, stress ulcer, as well as severe abdominal distension, diarrhea and other digestive and absorptive dysfunction; 3. Subjects with severe local broken skin which affects the use of continuous glucose monitoring (CGM) system; 4. Subjects who have concurrent severe malnutrition (body mass index [BMI] <15), severe hypertriglyceridemia (triglyceride≥5.6 mmol/L), severe hypoproteinemia (albumin<20 g/L), severe immunosuppression (neutrophils<1500/mm3 or lymphocytes<500/mm3), severe anemia (hemoglobin<60 g/L), severe infection, high fever and other stress conditions; 5. Subjects with fasting C-peptide < 100 pmol/L (0.3 ng/mL); 6. Subjects who are receiving intracranial pressure reduction therapy; 7. Patients with active malignant tumor (except for glioma, meningioma) or in the period of radiochemotherapy; 8. Patients with severe cardiac failure (New York Heart Association [NYHA] Class IV); those with severe liver or renal impaired function (glomerular filtration rate < 30 mL/min/1.73 m2, or levels of transaminases or transpeptidases more than 3 times the upper limit of normal); or those with conditions such as active hyperthyroidism, treatment-resistant hypothyroidism; 9. Subjects with one of the following conditions: hemodynamic instability, life-threatening multiple injuries, as well as severe acidosis, shock, sepsis; 10. Recent (within 3 months) acute complications of diabetes, such as diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome; 11. It is expected to perform magnetic resonance imaging during the routine study; 12. Subjects who have used systemic glucocorticoid therapy within 2 weeks prior to screening or are expected to use during the study; 13. Women who are pregnant or plan to become pregnant or are breastfeeding; 14. Life expectancy ≤ 30 days; 15. Participated in other interventional clinical trials within 4 weeks prior to screening, including those involved in drugs, nutritional preparations, medical devices, etc.; 16. Other cases not eligible for this study in the investigator's opinion, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), acute pancreatitis, unstable vital signs, and if it does, the reasons for ineligibility should be recorded.

Contacts and Locations

Contacts

Contact: Vincent Wang; +86 10 84348448; Vincent.wang2@cn.nestle.com

Locations

China

Peking Union Medical College hospital; Recruiting

Beijing, China

Sponsors and Collaborators

Société des Produits Nestlé (SPN)

Nestle Health Science

Investigators

• Principal Investigator: Wei Chen; Peking Union Medical College Hospital

More Information

• Responsible Party: Société des Produits Nestlé (SPN)
• ClinicalTrials.gov Identifier: NCT05859165
• Other Study ID Numbers: 22.01.CN.NHS
• First Posted: May 15, 2023
• Last Update Posted: May 15, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases